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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

A Look at FDA's FY2018 Generic Drug Performance

Eight months into Fiscal 2018, the US Food and Drug Administration (FDA) is on target to approve a similar number of generic drugs as it did the previous year.

In addition to FDA’s focus on boosting generic drug competition as a means of addressing prescription drug spending, Fiscal 2018 marks the first year of the agency's second generic drug user fee program, which features new performance goals and program enhancements.

FY2018 ANDA Performance

With the release of monthly performance data for the month of May on Monday, FDA says it has approved 496 abbreviated new drug applications (ANDAs) and tentatively approved another 114 ANDAs in Fiscal 2018.

Those numbers are on par with the agency's Fiscal 2017 performance. During the same period in 2017, FDA granted full approval to 477 ANDAs and tentative approval to 119 applications.

For the full 2017 fiscal year, FDA approved 763 ANDAs and tentatively approved another 174, with 63% of those approvals taking place in the second half of the year.

While FDA has touted 2017 as a record-setting year for generic drug approvals with 843 full abbreviated new drug applications (ANDA) approvals and 184 tentative approvals, October, November and December 2017 saw a much higher than normal number of approvals, boosting the number reported for the calendar year.

In January and February 2018, FDA saw a sharp decline in the number of approved ANDAs, with just 25 and 32 full approvals in those months. By March, and carrying on through May, those numbers have bounced back to around the agency's 2017 levels, with 57, 66 and 67 full approvals during those months.

Notably, in Fiscal 2018, FDA has already issued more complete responses for ANDAs than it did in the entire 2017 fiscal year.

The agency has also seen a decline in the number of new ANDA submissions in 2018, with 672 submissions through May. In the same period in 2017 the agency had received 877 ANDA submissions, with 1306 for the full fiscal year.